Kornimate/medical-research-clean huggingface dataset:
comparing magnetic resonance imaging/spectroscopy techniques

Conditions: Abdominal Organs - Lipodystrophy; Tumors

Summary: magnetic resonance imaging (mri) and magnetic resonance spectroscopy (mrs) are diagnostic tests that allow researchers to look at different chemical properties of tissue. magnetic resonance imaging and spectroscopy studies can be used to gather or evaluate information about various aspects of patient s bodies or to monitor changes in the biochemistry and physiology of patient s bodies. unlike other diagnostic techniques (ct scan and pet scan) mri and mrs do not use ionizing radiation. some studies have shown that mri is more effective at distinguishing normal parts of the anatomy from abnormal anatomy, especially in the brain. mri has become the diagnostic test of choice for evaluating patient with multiple sclerosis. the purpose of this study is to evaluate normal volunteers and patients with a variety of diseases with magnetic resonance imaging. researchers will attempt different magnetic resonance imaging methods and techniques as well as different levels of magnetic strength.

background: mri is a constantly evolving imaging modality. pulse sequences are often modified to improve their performance. however, many of these changes have not yet been approved by the fda and therefore, are not considered standard of care. some of these sequences require the use of new types of imaging coils, which are also investigational. objectives: the major purpose of this protocol is to inform patients undergoing mr scans in the clinical center that they be scanned with mri sequences and/or coils which may or may not be fda approved and to get the patient s consent for this. this is not a formal research study since specific disease entities and specific pulse sequences are not studied in a systematic way. rather, the purpose is to give nih patients access to gradual improvements in mr technology that would otherwise not be available to them. eligibility: all patients who, by virtue of the nih protocol in which they are enrolled, qualify for mri will be eligible for participation in this protocol. design: up to 99,999 participants will be enrolled in this study.

Eligibility criteria:
* inclusion criteria: * all patients undergoing mri in the clinical center. * patients must be able to provide informed consents. exclusion criteria: * contraindications to mri. * inability to understand consent form or consent process and the absence of a suitable guardian. * adults who are or may not be able to consent * patients in whom the scan must be performed quickly, i.e. those patients under anesthesia, anxious patients, those requiring emergency medical care, or others in which it is deemed inappropriate to prolong a study. * refusal to participate. * pregnant women and fetuses * neonates

Keywords: mr technology pulse sequences fda approved mri sequences investigational coils
a study of magnetic resonance imaging (mri) with gadavist in children

Conditions: Magnetic Resonance Imaging

Summary: in this clinical study a contrast agent for magnetic resonance imaging (mri), which has already been approved for application in adults, will be investigated in children and adolescents. mri is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. a special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. in contrast-enhanced mri a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced mri. the company bayer healthcare pharmaceuticals has developed a contrast agent for mri called gadavist 1.0 which was first approved in 1998 in switzerland for mri of brain and spine. since 2003 gadavist can also be used in magnetic resonance angiography (mra) in adults, i.e. in the mri examination of the blood vessels and since 2006 in mri of liver and kidney disease. gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. yet, clinical studies investigating gadavist have been only conducted with adults so far. diseases requiring mri examinations, however, often occur in children, too. therefore, many contrast agents are already used on a regular basis in mri examinations of children, some of these contrast agents being authorized already. within the framework of this study the pharmacokinetic characteristics of gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. in addition, safety and tolerability will be evaluated in order to demonstrate that gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.

please note that the present study is allocated two study phases, i.e. phase i and phase iii.

Eligibility criteria:
inclusion criteria: * patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years) who are scheduled to undergo gadolinium (gd)-enhanced mri of brain, spine, liver and/or kidneys or gd-enhanced mra (single field of view). exclusion criteria: * clinically unstable patients (e.g. intensive care unit) * renal insufficiency * patients undergoing a relevant change in chemotherapy \</= 48 hours prior to and up to 24 hours after the administration of gadovist.

Keywords: contrast-enhanced mri mr angiography (mra) children 2-17 years
nk dli in patients after human leukocyte antigen (hla)-haploidentical hematopoietic stem cell transplantation (hsct)

Conditions: Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Lymphoma; Neuroblastoma; Rhabdomyosarcoma

Summary: this is a phase i/ii study of highly selected donor lymphocyte infusions in patients undergoing hla-haploidentical hemopoietic stem cell transplantation. patients will be offered "pre-emptive" nk-dli early after hsct. three schedules of nk-cell infusion will be studied: basel patients (adult and pediatric) will receive nk-dli on days +40 and +100 (pre-emptive-late); frankfurt patients (pediatric) will receive nk-dli on days +3, +40, and +100 (pre-emptive early). patients not receiving pre-emptive nk-dli with loss in donor chimerism or with evidence of minimal residual disease will be offered "therapeutic" nk-dli.


Eligibility criteria:
inclusion criteria: * patients with acute/chronic leukemia, myelodysplastic syndrome, lymphoid neoplasia, solid tumor or bone marrow failure syndrome * signed informed consent of the patient (or his/her legal representative) exclusion criteria: * patients with graft failure * patients with any grade of active acute of chronic graft-versus-host disease (gvhd)
evaluation of innovated screening tools for type 2 diabetes among chinese population(sensible study i)

Conditions: Type II Diabetes Mellitus

Summary: evaluation of using 2h-ug combined with fpg, agesp alone or in combination with fpg in diabetes screening in chinese natural population

using the who criteria as the golden standard，drawing the roc curve of 2h-ug combined with fpg, agesp alone or in combination with fpg，calculating the area under the roc curve.

Eligibility criteria:
inclusion criteria: * 20\~70 year old urban and rural residents; * volunteer to participate in this study and sign informed consent. exclusion criteria: -

Keywords: advanced glycation end-product glycosuria
idys™ tlif 3dti post market clinical follow-up

Conditions: Degenerative Disc Disease; Grade 1 Spondylolisthesis

Summary: the aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of idys™ tlif 3dti at up to 24 months post transforaminal lumbar fusion in usual surgical practice.

the primary endpoint is to evaluate the effectiveness of the idys™ tlif (transforaminal lumbar interbody fusion) 3dti (porous titanium additive manufacturing) by measuring the evolution of the rate of fusion during the postoperative period. the secondary endpoints are to analyze the safety and the patient's benefit of the idys™ tlif 3dti by evaluating several point of view: * the adverse events related to the surgery; * the functional improvement between preoperative state and the different follow-up time points using the oswestry disability index (odi); * the improvement of back pain between preoperative state and the different follow-up time points using the visual analog scale (vas) (legs and back); * the evolution of several radiologic lumbar parameters to assess the correction and its stability.

Eligibility criteria:
inclusion criteria: * english speaking patients * patient with skeletal maturity * patient with * degenerative disc disease at one or two levels from l2 to s1 and/or * grade 1 spondylolisthesis * surgical treatment with idys tlif 3dti interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod). exclusion criteria: * off-label indications. * any medical or surgical condition which would preclude the potential benefit of spinal implant surgery. * any patient having a prior fusion at the level to be treated. * any patient being vulnerable * non-english speakers

Keywords: spine interbody fusion device
preoperative biliary drainage in resectable pancreatic or periampullary cancer

Conditions: Pancreatic Carcinoma

Summary: the purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (sems) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.


Eligibility criteria:
inclusion criteria: * age 18 or older * willing and able to comply with the study procedures and provide written informed consent to participate in the study * diagnosis of probable pancreatic cancer, distal common bile duct (cbd) cholangiocarcinoma and other periampullary cancers (histology not required) * biliary obstructive symptoms or signs * bilirubin level at/above 100 umol per liter (5.8 mg/dl) * distal biliary obstruction consistent with pancreatic cancer, distal cbd cholangiocarcinoma or other periampullary malignancy * location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum * patients deemed as resectable by pancreatic protocol ct or mri * surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion * surgery intent within 4 weeks * endoscopic and surgical treatment to be provided by same team exclusion criteria: * biliary strictures caused by confirmed benign tumors * biliary strictures caused by malignancies other than pancreatic cancer, distal cbd cholangiocarcinoma and other periampullary cancers * surgically altered biliary tract anatomy, not including prior cholecystectomy * neoadjuvant chemotherapy for current malignancy * palliative indication due to reasons other than surgical candidate status * previous biliary drainage by ercp/ptc * patients for whom endoscopic techniques are contraindicated * participation in another investigational trial within 90 days * pregnancy

Keywords: pancreatic periampullary cancer preoperative biliary drainage resectable
study of incb039110 in combination with docetaxel in subjects with non-small cell lung cancer

Conditions: NSCLC (Non-small Cell Lung Carcinoma)

Summary: the primary objectives of this study is to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (part 1, safety run-in portion).

sponsor decision to not initiate part 2 of the trial and part 2 of the study was not conducted. in part 2, the randomized portion, the objective is to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (nsclc) when treated with itacitinib in combination with docetaxel versus docetaxel alone. the secondary objectives of this study (part 2) are to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of nsclc that is stage iiib, iv, or recurrent. 2. received only 1 prior systemic chemotherapy regimen for stage iiib, iv, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (note: exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.) 3. eastern cooperative oncology group (ecog) performance status 0 to 2. 4. life expectancy of ≥12 weeks. exclusion criteria: 1. received prior treatment with docetaxel. 2. known active central nervous system (cns) metastases. subjects with cns metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as: 1. no evidence of new or enlarging cns metastasis or new neurological symptoms attributable to cns metastases. 2. subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry. 3. peripheral neuropathy ≥ grade 3. 4. current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy. 5. significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease. 6. unwilling to be transfused with blood components.

Keywords: stage iiib, iv, or recurrent non-small cell lung cancer
tearcare system to treat dry eye disease

Conditions: Dry Eye; Meibomian Gland Dysfunction

Summary: in this study, the tearcare system will be compared with the lipiflow thermal pulsation system in patients with dry eye disease. the objective is to demonstrate that the tearcare system is safe and effective in relieving the signs and symptoms of dry eye disease. note: all sites have been selected for this study. we are not seeking additional sites at this time.


Eligibility criteria:
key inclusion criteria: * at least 22 * subject has dry eye symptoms and uses artificial tears/lubricants regularly * subject has moderate to severe symptoms based on a dry eye questionnaire * subject has an abnormal tear break-up time * subject's eyelid glands secrete a low amount of meibum * best corrected visual acuity 20/100 or better * willing and able to comply with protocol * willing and able to provide consent * english-speaking key exclusion criteria: * use of medications that treat dry eye disease or that are known to cause ocular dryness. * use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, nsaids * prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, truetear within the past 2 weeks, or meibomian gland probing. * history of eyelid, conjunctival or corneal surgery within the past year. * contact lens use within past 2 weeks * ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.
comparison of the effects of two different exercise programs in obese adolescents

Conditions: Obesity, Adolescent

Summary: obesity is one of the most important health problems of developed and developing countries. especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. in obese individuals, the effects of postural control and balance have been reported to cause musculoskeletal problems, and motor control skills have been found to decrease. the aim of this study is to compare the effects of balance exercises and strengthening exercises on balance, posture and lower extremity functions in obese adolescents.


Eligibility criteria:
inclusion criteria: * individuals aged 12-18 body mass index to be 95 and above according to percentile values no exercise program in the past 6 months exclusion criteria: * having a medical condition that prevents exercise having a disease of neuromuscular origin presence of psychiatric or neurological diseases affecting cooperative and cognitive functions equilibrium effect due to another disease
opioid-induced bowel dysfunction (obd) pivotal assessment of lubiprostone (opal)

Conditions: Opioid-induced Bowel Dysfunction

Summary: the primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with opioid-induced bowel dysfunction.


Eligibility criteria:
inclusion criteria: a patient can be considered for eligibility to participate if he/she: * has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening * is diagnosed with obd * is capable of utilizing an electronic diary to report daily spontaneous bowel movements (sbms) * is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study exclusion criteria: a patient cannot be considered for eligibility to participate if he/she: * uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
study of coronary artery disease by two types of angiography

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to test the ability of a new x-ray technique called ct angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram.

objective: in patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography. this procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality. with the advent of multidectector row-computed tomography technology, it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity. the goal of this study is to compare non-invasive computed tomography (ct) angiography with traditional coronary angiography to identify proximal, and hence revascularizable, coronary artery disease in patients with cardiomyopathy. revascularizable is defined a 3 vessel proximal disease, left main disease, or left main equivalent disease (ostial left anterior descending and ostial left circumflex). research design: this study is prospective, interventional, single site with the interpreting radiologists blinded to the results from previous angiography. methods: subjects will be patients with cardiomyopathy, defined as an ejection fraction less than 40%. exclusion criteria include known allergy to contrast medium, previous anaphylaxis, and renal insufficiency (serum creatinine greater than 1.5). we would like to enroll 30 patients. after giving informed consent, all eligible patients will undergo ct angiography, performed using new multi-slice technology. the results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed. following ct angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy. results of the ct angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease, compared to coronary angiography as the gold standard.

Eligibility criteria:
inclusion criteria: * congestive heart failure with ef\<40% * age\> 18 years exclusion criteria: * contrast allergy * renal insufficiency * inability or unwillingness to sign a consent * diabetes mellitus

Keywords: congestive heart failure, lv dysfunction
benefit of augmented reality mirror therapy in addition to conventional management in complex regional pain syndrome of the upper extremity

Conditions: Complex Regional Pain Syndromes

Summary: complex regional pain syndrome (crps) is a "polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes". the diagnostic criteria of the disease follow the budapest criteria, namely (i) vasomotor disorders (temperature asymmetry, color changes), (ii) sudomotor/oedema (sweating changes, edema), (iii) sensory (hyperesthesia, allodynia, hyperalgesia) and (iv) motor/trophic (reduced joint mobility, weakness, tremor, dystonia, trophic disorders of skin, nails, hair). of the many treatments, augmented reality mirror therapy (armt), is novel in substituting a virtual environment for part of the real environment. this type of device has never been studied from a clinical point of view in the treatment of upper limb crps, whereas fmri and clinical dissertation studies have suggested an improvement in neuroplasticity. the aim of this study is to establish the clinical effects of armt on crps, and to evaluate its benefit within a conventional rehabilitation treatment (physiotherapy and occupational therapy).


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * patient with crps of the upper limb according to the budapest criteria. * patient newly treated at the centre d'evaluation et de traitement de la douleur of the chu of nîmes. * patient with a diagnosis of crps for more than 3 months exclusion criteria: * the subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study * the subject unable to express consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient is pregnant, parturient or breastfeeding * patient with medically significant visual impairment that is incompatible with the practice of armt * patient with crps secondary to a stroke * patient with cognitive disorders (montreal cognitive assessment scale less than 26) * patient with unilateral spatial negligence according to the bell's test * patient with arthrodesis of one of the joints of the upper limbs. * patient with an unhealed fracture of one of the upper limbs

Keywords: mirror movement therapy physical therapy modalities
open-label study of tak-875

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of treatment with tak-875 in diabetic patients.


Eligibility criteria:
inclusion criteria: 1. the participant is an outpatient. 2. the participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: 1. the participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. 2. the participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.

Keywords: drug therapy